New DEA Telehealth Prescribing Rules Released
| Last week the U.S. Drug Enforcement Administration (DEA) released three new rules impacting prescribing controlled substances via telehealth, including the long-awaited regulations regarding establishing a telehealth prescribing registration process that was first mandated by Congress back in 2008. While the registration regulation is a proposed rule, the two additional rules regarding buprenorphine and Veterans Affairs providers are final rules: Proposed Rule – Special Registrations for Telemedicine and Limited State Telemedicine RegistrationsFinal Rule – Expansion of Buprenorphine Treatment via Telemedicine EncounterFinal Rule – Continuity of Care via Telemedicine for Veterans Affairs PatientsEach of the rules seek to create permanent exceptions to the existing in-person evaluation requirement related to the prescribing of controlled substances. Readers may recall that the DEA’s current permanent telehealth prescribing policies have been waived since the onset on the COVID-19 public health emergency (PHE) with the current temporary waiver currently slated to expire at the end of 2025. While these final and proposed regulations by the DEA would expand permanent policies, they will not be as broad as what has been seen during the temporary waiver period. SPECIAL REGISTRATION RULE This proposed rule would create a special registration framework that authorizes three types of telemedicine registration, in addition to additional prescribing, recordkeeping, and reporting requirements. The special registration framework requires registrants to utilize both audio and video components of an audio-video telecommunication system for each telemedicine encounter. The three types of special registration, include:The Telemedicine Prescribing Registration, authorizing qualified clinician practitioners to prescribe Schedule III-V controlled substances;The Advanced Telemedicine Prescribing Registration, authorizing qualified specialized clinician practitioners (such as psychiatrists and hospice physicians) to prescribe Schedule II-V controlled substances; andThe Telemedicine Platform Registration, authorizing qualified covered online telemedicine platforms, in their capacity as platform practitioners, to dispense Schedule II-V controlled substances (through providers possessing either of the above registrations). The proposed rule also requires special registrants to maintain a State Telemedicine Registration issued by the DEA for every state in which a patient is treated by the special registrant, unless otherwise exempted. Using a new registration application form, known as Form 224S, the three types of Special Registrations (Telemedicine Prescribing Registration, Advanced Telemedicine Prescribing Registration, and Telemedicine Platform Registration), and the State Telemedicine Registration (one type for clinician special registrants and one type for platform special registrants) would be on a three-year cycle. Applicants are required to already hold one or more DEA registrations to prescribe or dispense controlled substances. For additional information on special registration eligibility by provider type and limited exemptions to the state telemedicine registration requirement, as well as proposed registration processes, fees and reporting requirements, please see the proposed rule in its entirety. According to the proposed rule, special registration prescriptions must be prescribed through electronic prescribing for controlled substances (EPCS), and after the special registrant has verified the identity of the patient. Providers also must conduct a nationwide Prescription Drug Monitoring Program (PDMP) check of all 50 states and any U.S. district or territory that maintains its own PDMP. However, the nationwide PDMP check requirement would have a delayed effective date of three years. Meanwhile, for all Schedule II-V controlled substances, registrants are required to conduct a PDMP check of: The state/territory where the patient is located;The state/territory where the clinician special registrant is located; andAny state/territory that has a PDMP reciprocity agreement with the states/territories where the patient and clinician special registrant are located.Additionally, special registration prescriptions will require the inclusion of the Special Registration numbers of the clinician special registrant and the platform special registrant (if a platform special registrant facilitated the prescription), and State Telemedicine Registration numbers. The DEA believes this requirement will additionally help pharmacists verify legitimate prescriptions and limit “red flags” from being inappropriately attached to telehealth prescriptions. The DEA specifies in the rule that the special registration process and related requirements do not apply in situations where a prior in-person evaluation has occurred, if the encounter meets one of the other current exceptions for telehealth, as well as in situations captured by the new finalized rules specific to buprenorphine and Veterans Affairs providers (which are discussed more below). The DEA also clarifies that special registrants still need to comply with the laws and regulations of the state in which registered, and the laws and regulations of the state in which they are issuing special registration prescriptions via a telemedicine encounter. This includes state laws governing standards of medical practice and requirements around establishing patient-provider relationships prior to prescribing. Registrants also must be present in the United States during the time of the telehealth visit and when issuing prescriptions. For Schedule II controlled substances, given the higher potential for abuse and dependence, the DEA proposes two additional requirements: The clinician special registrant must be physically located in the same state as the patient when issuing a special registration prescription for a Schedule II controlled substanceThe average number of special registration prescriptions for Schedule II controlled substances constitutes less than 50 percent of the total number of Schedule II prescriptions issued by the clinician special registrant in their telemedicine and non-telemedicine practice in a calendar month Lastly, the DEA rule seeks to account for different telehealth models by specifically addressing online telemedicine platforms employing a direct-to-consumer (DTC) business model. The rule determines the platforms to be serving as prescribing and dispensing intermediaries, and therefore falling under broad statutory definitions for practitioners, which must be qualified and accountable to the DEA. The rule discusses concerns specific to the DTC model justifying the need to consider them as a certain subset of practitioners, including practices that may incentivize inappropriate prescribing and limit provider access to patient records (find more information in CCHP’s June 2024 Differences Between Teletherapy and Platform Therapy newsletter). The proposed DEA rule defines “covered online telemedicine platforms” while exempting hospitals, clinics, insurers, as well as “local in-person medical practices”, to differentiate between the models and ensure application of the special registration requirements appropriately. Additional criteria are attached to determining status as a covered online telemedicine platform, including meeting one or more of the following: The entity explicitly promotes or advertises the prescribing of controlled substances through the platform;The entity has financial interests, whether direct incentives or otherwise, tied to the volume or types of controlled substance prescriptions issued through the platform, including but not limited to, ownership interest in pharmacies used to fill patients’ prescriptions, or rebates from those pharmacies;The entity exerts control or influence on clinical decision-making processes or prescribing related to controlled substances, including, but not limited to: prescribing guidelines or protocols for clinician practitioners employed or contracted by the platform; consideration of clinician practitioner prescribing rates in the entity’s hiring, retention, or compensation decisions; imposing explicit or de facto prescribing quotas; directing patients to preferred pharmacies; and/orThe entity has control or custody of the prescriptions or medical records of patients who are prescribed controlled substances through the platform.This proposed rule was published in the Federal Register on January 17, 2025. Public comments must be submitted, and written comments must be postmarked, on or before 60 days after that date of publication, which would be March 18, 2025. Comments will not be accepted after 11:59 p.m. Eastern Time on the last day of the comment period. The proposed rule contains many other specific details regarding the three proposed registries, including a section on required documentation and data collection. CCHP highly encourages you to read the full proposal if the topic is of interest to you. BUPRENORPHINE RULE Existing law authorizes telemedicine prescribing only in specified circumstances when no in-person visit has occurred. This new buprenorphine rule additionally falls under existing exceptions and is a finalized version of the March 2023 proposed rule,Expansion of Induction of Buprenorphine via Telemedicine Encounter. The final rule has been modified, however, to address comments and concerns raised with the proposed version. The DEA also stresses that the limitations and requirements within the final rule do not apply to provider-patient relationships where a prior in-person medical evaluation has occurred. Under the rule, DEA-registered providers are authorized to prescribe buprenorphine for treatment of opioid use disorder (OUD) via audio-only or audio-video telemedicine as follows: A DEA-registered practitioner, prior to issuing a prescription via telemedicine for a schedule III-V controlled substance approved by the Food and Drug Administration (FDA) for use in the treatment of opioid use disorder (OUD), must review the prescription drug monitoring program (PDMP) data of the state in which the patient is located when the telemedicine encounter occursThe practitioner is authorized to prescribe up to an initial six-month supply (split amongst several prescriptions totaling six calendar months); additional prescriptions may be issued under other forms of telemedicine as authorized bythe Controlled Substances Act (CSA) or after an in-person medical evaluation is conductedThe pharmacist must verify the identity of the patient prior to filling the prescriptionThe main changes between the new final rule and the 2023 proposed rule include expanding the initial 30-day prescription supply limitation via audio-only to a six-month supply, and removing in-person requirements for subsequent prescriptions. Since it is possible a patient will not be seen in-person by the prescribing practitioner at any point, the DEA added the pharmacist identification verification requirement. Additionally, many of the recordkeeping requirements from the proposed rule have been removed within the final rule. In regard to the PDMP review requirement prior to prescribing, the provider will need to annotate date and times of PDMP review. If the PDMP is unavailable or inaccessible, review attempts should also be noted while the provider can continue to prescribe renewable seven-day prescriptions until the six-month limit is reached, and while continuing to attempt to review the PDMP every seven days. This rule is effective 30 days after publication in the Federal Register, which was on January 17, 2025; therefore, the rule will be effective February 18, 2025. VETERANS AFFAIRS RULE This rule finalizes the VA portion of the March 2023 proposed rule, Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient have Not Had a Prior In-Person Medical Evaluation. The rule authorizes Department of Veterans Affairs (VA) practitioners acting within the scope of their VA employment to prescribe controlled substances via telemedicine to a VA patient with whom they have not conducted an in-person medical evaluation, if another VA practitioner has, at any time, previously conducted an in-person medical evaluation of the VA patient, subject to certain conditions. These conditions include reviewing both the patient’s VA electronic health record (EHR), which includes the internal VA prescription database, and the prescription drug monitoring program (PDMP) data for the state in which the VA patient is located at the time of the telemedicine encounter (if the state has such a program). If the VA EHR or state PDMP are unavailable or inaccessible, the practitioner must limit the prescription to a 7-day supply and must later review both the patient’s VA EHR and the PDMP data for the state in which the patient is located at the time of the telemedicine encounter before continuing to prescribe controlled substances to the patient via telemedicine. If no PDMP program exists for the state in which the VA patient is located, the provider must review the VA EHR prior to issuing a prescription for more than a 7-day supply. The DEA notes that this rule does not apply to contracted practitioners located outside a VA facility or clinic providing care via the community care network (CCN) or conducting disability compensation evaluations. The DEA notes that while this rule is specific to VA practitioners given the unique closed system in which they operate, the DEA is committed to periodically evaluating whether extending this authority to non-VA practitioners may be appropriate in the future. Meanwhile, the DEA references and directs the public to the proposed Special Registration rule, which addresses telehealth prescribing for non-VA practitioners. In the meantime, the DEA’s temporary in-person requirement exemption implemented at the beginning of the COVID-19 PHE has been extended through December 31, 2025, while they work to establish permanent policies applicable to non-VA providers. This final rule is effective 30 days after publication in the Federal Register, which was on January 17, 2025, making the rule effective February 18, 2025. The DEA notes its decision in the VA rule to not adopt the broader telemedicine prescribing scheme initially proposed in the March 2023 proposed rule, Telemedicine Prescribing of Controlled Substances When the Practitioner and the Patient have Not Had a Prior In-Person Medical Evaluation. That rule received a total of 35,454 comments and was subject to considerable concern and pushback from stakeholders. Many in the telehealth community also lamented the lack of regulations addressing telehealth registration at that time, to which the DEA has also responded with its newly proposed special registration rule. Nevertheless, recent articles released in response to the new rules seem to indicate many stakeholder concerns remain related to the additional restrictions and requirements included, such as those related to limiting certain telehealth prescriptions to a specific percentage and checking PDMPs nationwide. Some have also asserted the rules may not have been quite ready but were released to ensure they were not lost amidst the forthcoming federal administration change. Again, while the more tailored regulations specific to buprenorphine and the VA are now final, the special registration regulations are still simply proposed and subject to change. Additionally, the public has 60 days to provide comments on the registration proposal. For more information on the new DEA rules, please view the regulations in their entirety:Proposed Rule – Special Registrations for Telemedicine and Limited State Telemedicine Registrations; Final Rule – Expansion of Buprenorphine Treatment via Telemedicine Encounter; Final Rule – Continuity of Care via Telemedicine for Veterans Affairs Patients. |